Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer

Cepheid17 sites in 3 countries424 target enrollmentDecember 2016

ConditionsBladder Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Cepheid
Enrollment: 424
Locations: 17
Primary Endpoint: Comparison to histology for positive or suspicious cystoscopy
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

May 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cepheid

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥ 40 years of age
•Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states.
•Subject is considered disease positive within 12 months (365 days) of enrollment.
•At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen.
•Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit.
•Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort.
•Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled.
•Subject has been previously enrolled into the study.
•Urine specimen to be used for study purposes is from the first morning void.
•Subject has had an excision procedure within six weeks (42 days) of enrollment.